Healthy
Conditions
Brief summary
Study to determine the pharmacokinetic effect of BILR 355 + ritonavir® on TRUVADA and TRUVADA on BILR 355
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and Females who meet the inclusion/
Exclusion criteria
; females must not be pregnant or nursing, and must agree to use a double-barrier method of birth control (condoms or diaphragm, plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives) * Age ≥18 and \<60 years * Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2 * Ability to give signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local regulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from 0 to 24 hours at steady state of the analyte in plasma (AUC0-24h,ss) | up to 24 h after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss) | up to day 18 after start of treatment |
| Measured concentration of the analyte in plasma 24 hours post last dose at steady state (Cp24h, ss) | up to 24 h after treatment |
| Terminal half-life of of the analyte in plasma in the plasma at steady state (t1/2, ss) | up to day 18 after start of treatment |
| Apparent volume of distribution of of the analyte in plasma during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss) | up to day 18 after start of treatment |
| Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss) | up to day 18 after start of treatment |
| Maximum measured concentration of ritonavir in plasma (Cmax) | up to 24 h after treatment |
| Number of subjects with clinically relevant changes in clinical laboratory tests | up to day 28 after start of treatment |
| Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate) | up to day 28 after start of treatment |
| Number of subjects with adverse events | Up to 7 weeks |
| Area under the concentration-time curve from 0 to 24 hours of ritonavir in plasma (AUC0-24h) | up to 24 h after treatment |
Outcome results
None listed